Organ Care System (OCS) Lung System

FDA Premarket Approval P160013 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

For a change in the material of the large valve ball of the ocs perfusion module.

DeviceOrgan Care System (OCS) Lung System
Generic NameNormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
ApplicantTransMedics, Inc
Date Received2019-09-23
Decision Date2019-12-20
PMAP160013
SupplementS006
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TransMedics, Inc 200 Minuteman Road suite 302 andover, MA 01810

Supplemental Filings

Supplement NumberDateSupplement Type
P160013Original Filing
S009 2022-02-07 Real-time Process
S008 2021-05-04 Real-time Process
S007 2020-09-04 Real-time Process
S006 2019-09-23 Real-time Process
S005 2019-09-23 Real-time Process
S004
S003 2018-09-27 Real-time Process
S002
S001 2018-04-06 Normal 180 Day Track No User Fee

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